NCT01150682

Brief Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is studying the role of biomarkers in endometrial cancer recurrence in samples from patients with stage II, stage III, or stage IV endometrial cancer.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
865

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

April 29, 2011

Status Verified

August 1, 2010

Enrollment Period

5 years

First QC Date

June 24, 2010

Last Update Submit

April 28, 2011

Conditions

Endometrial Cancer

Keywords

endometrial adenocarcinomastage II endometrial carcinomastage III endometrial carcinomastage IV endometrial carcinomaendometrial adenosquamous cell carcinomaendometrial clear cell carcinomaendometrial papillary serous carcinoma

Outcome Measures

Primary Outcomes (7)

  • Patient characteristics: age, BMI, performance status, race, ethnicity

  • Tumor characteristics

  • Surgical compliance and type of surgical adjuvant therapy

  • Overall survival

  • Recurrence-free survival

  • Site of first recurrence

  • Biomarker values and expression levels

Interventions

RNA analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
enzyme-linked immunosorbent assayOTHER
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed endometrioid endometrial cancer * Stage II-IV disease * Patients who were eligible and evaluated on the GOG-0210, Molecular Staging in Endometrial Cancer clinical trial, meeting the following criteria: * Allowed their specimens and clinical data collected as part of their participation * Have sufficient high-quality frozen primary tumor, formalin-fixed and paraffin-embedded (FFPE) primary tumor, and/or pre-operative serum for testing available * Patients who underwent surgical staging as specified in the GOG-0210 protocol and described in the GOG Surgical Manual Protocol, including any of the following procedures: * Hysterectomy * Bilateral oophorectomy * Washings as well as pelvic lymphadenectomy and para-aortic lymphadenectomy * Non-cancerous endometrial tissue and fasting serum from control samples meeting the following criteria (controls): * Underwent hysterectomy to treat uterine prolapse at the Albert Einstein Hospital and Montefiore Medical Center, in the Bronx, NY * No uterine fibroids or prior cancer PATIENT CHARACTERISTICS: * Postmenopausal patients and controls PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Reverse Transcriptase Polymerase Chain ReactionEnzyme-Linked Immunosorbent AssayImmunohistochemistry

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Polymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesImmunoenzyme TechniquesImmunoassayImmunologic TechniquesImmunosorbent TechniquesMolecular Probe TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological Techniques

Study Officials

  • Marc Gunter, PhD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NETWORK

Study Record Dates

First Submitted

June 24, 2010

First Posted

June 25, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2015

Last Updated

April 29, 2011

Record last verified: 2010-08